Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

PHASE1CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

April 9, 2015

Primary Completion Date

June 16, 2016

Study Completion Date

March 6, 2020

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

ceritinib

The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.

Trial Locations (73)

110

Novartis Investigative Site, Taipei

1210

Novartis Investigative Site, Vienna

1303

Novartis Investigative Site, Sofia

2650

Novartis Investigative Site, Edegem

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10990

Novartis Investigative Site, Pulau Pinang

12351

Novartis Investigative Site, Berlin

20080

Novartis Investigative Site, Donostia / San Sebastian

20141

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

20850

Maryland Oncology Hematology, P.A. SC-2, Rockville

24127

Novartis Investigative Site, Bergamo

25123

Novartis Investigative Site, Brescia

28050

Novartis Investigative Site, Madrid

28100

Novartis Investigative Site, Novara

28222

Novartis Investigative Site, Madrid

29615

Greenville Health System SC, Greenville

31008

Novartis Investigative Site, Pamplona

33081

Novartis Investigative Site, Aviano

33305

Novartis Investigative Site, Taoyuan District

37126

Novartis Investigative Site, Verona

38039

Novartis Investigative Site, Talas / Kayseri

40138

Novartis Investigative Site, Bologna

40447

Novartis Investigative Site, Taichung

41009

Novartis Investigative Site, Seville

46202

Goshen Center for Cancer Care IU Health - SC, Indianapolis

47014

Novartis Investigative Site, Meldola

51109

Novartis Investigative Site, Cologne

65653

Novartis Investigative Site, Brno

71013

Novartis Investigative Site, San Giovanni Rotondo

72703

Highlands Oncology Group, Fayetteville

84106

Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City

90110

Novartis Investigative Site, Hat Yai

92354

Loma Linda University, Loma Linda

93053

Novartis Investigative Site, Regensburg

93586

Novartis Investigative Site, Kuching

97074

Novartis Investigative Site, Würzburg

166484

Novartis Investigative Site, El Achrafiyé

197343

Novartis Investigative Site, Saint Petersburg

422002

Novartis Investigative Site, Nashik

700063

Novartis Investigative Site, Kolkata

07109

Essex Oncology of North Jersey PA SC, Belleville

Unknown

Novartis Investigative Site, Grafton

Novartis Investigative Site, Auckland

Novartis Investigative Site, Montería

A-1140

Novartis Investigative Site, Vienna

59075 740

Novartis Investigative Site, Natal

99010-260

Novartis Investigative Site, Passo Fundo

90601-000

Novartis Investigative Site, Porto Alegre

88301-229

Novartis Investigative Site, Itajaí

14784 400

Novartis Investigative Site, Barretos

01246 000

Novartis Investigative Site, São Paulo

T6G 1Z2

Novartis Investigative Site, Edmonton

L8V 5C2

Novartis Investigative Site, Hamilton

K1H 8L6

Novartis Investigative Site, Ottawa

M5G 2M9

Novartis Investigative Site, Toronto

115 27

Novartis Investigative Site, Athens

GR14564

Novartis Investigative Site, Athens

500 034

Novartis Investigative Site, Hyderabad

560 095

Novartis Investigative Site, Bangalore

110 085

Novartis Investigative Site, Delhi

00155

Novartis Investigative Site, Roma

3435 CM

Novartis Investigative Site, Nieuwegein

80 952

Novartis Investigative Site, Gdansk

62 500

Novartis Investigative Site, Konin

39-400

Novartis Investigative Site, Tarnobrzeg

05505

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

CH63 4JY

Novartis Investigative Site, Metropolitan Borough of Wirral

NE7 7DN

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY